In this single-dose-one arm, open label two way parallel design, pharmacokinetic study of two marketed formulations of Erythromycin using 12 healthy Indian male subjects the pharmacokinetic parameters of two marketed Erythromycin topical formulations were compared. Marketed Erythromycin topical formulations (A & B) were applied on the pre-marked forearms of the subjects as per the dosing schedule. Treatment sample B was used as a reference sample. Subjects received treatment A & treatment B on both the arms simultaneously, following open label two way parallel design. Skin Stratum Corneum samples were collected in sterile glass test tubes during the study period. The samples were collected pre-dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, & 6.0 hours post-dose application. The Stratum Corneum samples were analysed for Erythromycin concentrations only. Pharmacokinetic parameters of Erythromycin were calculated as Cmax, tmax, AUC (0-t) and AUC (0-∞) Erythromycin was estimated in Stratum Corneum using a validated Spectroscopic method. If the point estimate of the geometric mean ratio and the confidence intervals for the entire log transformed pharmacokinetic parameters [Cmax, AUC (0-t) and AUC (0-∞)] were entirely included in the range of 80-125%, then the treatments were claimed to be bio-equivalent. A total of 12 subjects were enrolled in this study. The bioequivalence values of the test drug A were Cmax of 23.767±2.398 μg/ml, tmax of 1.75 ±0.261 h, AUC0-t of 100.507± 10.455 h. μg/ml, AUC0-∞ of 178.286± 22.859 h. μg/ml; of the test drug B Cmax of 24.084± 2.216 μg/ml, tmax of 1.75 ±0.261 h, AUC0-t of 100.586±11.15 h. μg/ml, AUC0-∞ of 179.887± 21.553 h. μg/ml.
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